ODS

Wound Covering (Composite Cultured Skin)

产品代码

ODS

器械名称

Wound Covering (Composite Cultured Skin)

管理类别

第 F 类（HDE）

FDA 专业组

Unknown

上市路径

HDE - Humanitarian Device Exemption

标记

属植入器械

FDA 分类定义

Wound covering. Indicated for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (rdeb) as an adjunct to standard autograft procedures (i.E., skin grafts and flaps) for covering wounds and donor sites created after the surgical release of hand contractures (i.E., ?mitten? hand deformities).

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。